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A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease

StatusRecruiting
PhasePhase 1
Started2025-10-15
View on ClinicalTrials.gov ↗

Amendment history

2026-09-10
Study Status v11
Re-verified, no change to tracked fields
2026-08-12
Study Status, Contacts/Locations v10
Study sitesdetails revised at 1 of 13 sites
2026-07-22
Study Status, Contacts/Locations v9
Study sitesdetails revised at 2 of 13 sites
2026-06-10
Study Status, Contacts/Locations v8
Study sitesdetails revised at 3 of 13 sites
2026-05-12
Study Status, Oversight, Contacts/Locations v7
Study sites11→13
2026-04-23
Study Status, Oversight, Contacts/Locations v6
Study sitesdetails revised at 7 of 11 sites
2026-04-16
Study Status, Contacts/Locations v5
Trial sites expanded: 6 → 11 locations
2026-03-30
Study Status v4
Re-verified, no change to tracked fields
2026-02-19
Study Status, Contacts/Locations v3
Primary completion date2030-03-31→2030-03-06
Completion date2030-03-31→2030-03-06
Study sites13→6
2025-12-18
Study Status, Contacts/Locations v2
Study sitesdetails revised at 10 of 13 sites
2025-11-12
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-10-09→confirmed 2025-10-15
Study sitesdetails revised at 13 of 13 sites
2025-10-06
Original filing
The purpose of this study is to: * Evaluate the safety and tolerability of intrathecal (IT) ALN-5288 in patients with Alzheimer's Disease (AD) * Evaluate the pharmacodynamic (PD) and pharmacokinetic (PK) effects of ALN-5288 after dose administration
Trial Details
NCT Number NCT07214727
Lead Sponsor Alnylam Pharmaceuticals
Collaborators: Regeneron Pharmaceuticals
Conditions Alzheimer's Disease
Enrollment 50 participants
Start Date 2025-10-15
Primary Completion 2030-03-06 (estimated)
Study Completion 2030-03-06 (estimated)
Updated on ClinicalTrials.gov 2026-09-14